Methods and treatment for reducing the risk of an inflammatory response
Inventors
D'Alessandro, Angelo • Cordero, Rafael • Dunham, Andrew • Keegan, Philip • Yoshida, Tatsuro
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Assignees
MemberHemanextHemanextHemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Hemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Publication Number
US-11090331-B2
Publication Date
2021-08-17
Expiration Date
Abstract
Method for transfusion medicine to reduce adverse events in transfusion patient populations based on underlying patient physiology. Methods for reducing the risk of an inflammatory response in a sickle cell patient in need of a blood transfusion.
Core Innovation
The invention discloses transfusion methods using oxygen-reduced stored blood prepared with an initial oxygen saturation [procedural detail omitted for safety] prior to storage. When stored and transfused, the blood exhibits reduced pro-inflammatory mediators (leukotriene B4, HETEs, thromboxane B2, RANTES, eotaxin-1, sCD40L), reduced methemoglobin and beta-hemoglobin H93 oxidation, reduced microparticle formation and PIP→PIP3 signaling, and increased antioxidant and metabolic markers including NADPH, GSH, ATP, 2,3-DPG, methylene-THF, cysteine, glutamate, and urate.
The background identifies inflammatory and oxidative sequelae of conventionally stored blood that contribute to adverse clinical events. Elevated inflammatory mediators, hemoglobin oxidation, microparticle formation, and depleted antioxidant and metabolic reservoirs are implicated in transfusion-related acute lung injury, systemic inflammatory response syndrome, multiple organ dysfunction syndrome, delayed hemolytic transfusion reaction, and eryptosis.
The invention addresses these risks by reducing inflammatory mediators and preserving red cell biochemical and membrane physiology, and links biochemical improvements to reduced clinical risks on transfusion. It further claims identifying patients at increased risk of an inflammatory response and providing oxygen-reduced stored blood in defined clinical contexts, with methods and sampling for evaluation described with [procedural detail omitted for safety].
Claims Coverage
The patent includes one independent claim directed to a transfusion method; the coverage identifies three main inventive features related to the composition and comparative inflammatory profile of oxygen-reduced stored blood.
Administer oxygen-reduced stored blood
A method comprising administering oxygen-reduced stored blood for transfusion into a human patient in need of a blood transfusion, including a sickle cell human patient, to reduce the risk of an inflammatory response.
Initial oxygen saturation prior to storage
The oxygen-reduced stored blood has an initial oxygen saturation [procedural detail omitted for safety] prior to being stored for a storage period.
Reduced inflammatory factor levels compared to non-oxygen-reduced stored blood
The oxygen-reduced stored blood exhibits a reduced level of at least one inflammatory factor when compared to non-oxygen-reduced stored blood stored for an identical storage period.
The independent claim centers on administering oxygen-reduced stored blood characterized by a low initial oxygen saturation and demonstrably reduced inflammatory factor levels relative to identically stored conventional blood, including application to sickle cell patients, with dependent claims adding storage-duration, specific biomarker, and clinical-context refinements.
Stated Advantages
Reduces risk of an inflammatory response, including in a sickle cell human patient receiving a blood transfusion.
Reduces inflammatory and oxidative risk versus conventionally stored blood.
Reduces levels of pro-inflammatory eicosanoids and inflammatory mediators (leukotriene B4, HETEs, thromboxane B2, RANTES, eotaxin-1, sCD40L).
Lower oxidative protein and lipid damage, including reduced oxidation of beta-hemoglobin at H93, lower methemoglobin, and reduced dioxidation of GAPDH Cys152.
Reduces eryptosis and vesiculation, including reduced PIP→PIP3 phosphorylation and reduced microparticle formation.
Increases antioxidant and metabolic markers and reservoirs (NADPH, NADPH/NADP+, NAD/NADH, GSH, GSH/GSSG ratio, ATP, 2,3-DPG, methylene-THF, glutamate, cysteine, urate).
Reduces risk of transfusion-related adverse events including TRALI, SIRS, MODS, delayed hemolytic transfusion reaction, and eryptosis.
Improved outcomes in SIRS/MODS, sickle cell disease, thalassemia, massive or chronic transfusion, peri-operative settings, trauma, and diabetes.
Documented Applications
Reducing the risk of an inflammatory response in sickle cell human patients in need of a blood transfusion by administering oxygen-reduced stored blood.
Transfusion for thalassemia patients.
Use in systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) to improve outcomes.
Mitigation of ischemia–reperfusion injury.
Use in massive or chronic transfusion and trauma patients.
Use in peri-operative transfusion.
Providing oxygen-reduced stored blood to patients at increased risk of inflammatory complications, including chronic obstructive pulmonary disease, inflammatory bowel disease, ischemic heart disease, diabetes, Behçet's disease, and rheumatoid arthritis.
Use in specified transfusion contexts and clinical settings including multiple transfusions, vaso-occlusive crisis, and assessments tied to transcranial Doppler velocity.
Reduction of delayed hemolytic transfusion reactions.
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